Trials / Completed
CompletedNCT05759949
First-in-Human Study of RLY-5836 in Advanced Breast Cancer and Other Solid Tumors
A First-in-Human Study of PI3Kα Inhibitor, RLY-5836, in Combination With Targeted and Endocrine Therapies in Participants With Advanced Breast Cancer and as a Single Agent in Advanced Solid Tumors
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 41 (actual)
- Sponsor
- Relay Therapeutics, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is a Phase 1, first-in-human, open-label study designed to evaluate the maximum tolerated dose (MTD), recommended phase 2 dose (RP2D), safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary anti-tumor activity of RLY-5836 in advanced solid tumors in participants harboring a PIK3CA mutation in blood and/or tumor per local assessment. The study consists of 2 parts, a dose escalation (Part 1) and a dose expansion (Part 2).
Conditions
- PIK3CA Mutation
- Solid Tumor, Adult
- HER2-negative Breast Cancer
- Breast Cancer
- Metastatic Breast Cancer
- Advanced Breast Cancer
- Unresectable Solid Tumor
- Hormone Receptor Positive Tumor
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | RLY-5836 | RLY-5836 is a mutant-selective, oral PI3Kα inhibitor. |
| DRUG | Fulvestrant | Fulvestrant (500 mg) is administered IM into the buttocks (gluteal area) slowly (1 to 2 minutes per injection) as 2×5 mL injections, 1 in each buttock, on Cycle 1 Day 1, Cycle 1 Day 15, and Day 1 of each subsequent cycle. |
| DRUG | Palbociclib | Palbociclib 125 mg once daily is taken orally in combination with RLY-5836 and fulvestrant for 28-day cycles that include 21 days of treatment followed by 7 days off treatment. |
| DRUG | Ribociclib | Ribociclib 600 mg once daily is taken orally in combination with RLY-5836 and fulvestrant for 28-day cycles that include 21 days of treatment followed by 7 days off treatment. |
| DRUG | Abemaciclib | Abemaciclib 150 mg BID will be taken orally in combination with RLY-5836 and fulvestrant for 28-day cycles. |
Timeline
- Start date
- 2023-03-29
- Primary completion
- 2025-03-18
- Completion
- 2025-04-11
- First posted
- 2023-03-08
- Last updated
- 2025-05-16
Locations
7 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05759949. Inclusion in this directory is not an endorsement.